Castle Biosciences has received assay approval from the New York State Department of Health (NYSDOH) in the US for its TissueCypher Barrett’s oesophagus (BO) test.
The Texas-based diagnostics company claims TissueCypher is the first AI-driven precision medicine test that is designed to predict a patient’s risk of progression from BO to oesophageal cancer.
More common in men than women, BO is a complication, most commonly the result of gastroesophageal reflux disease (GERD), wherein the cellular structure in the lining of an individual’s oesophagus begins to change, potentially increasing their risk of developing oesophageal cancer. Research estimates the prevalence of BO in the US at around 5%.
According to Cancer Research UK, between three and 13 people out of 100 with BO in the UK will develop oesophageal adenocarcinoma in their lifetime.
TissueCypher analyses cancer-associated biomarkers to identify a molecular signature of BO progression that can precede visible tissue changes in a patient’s oesophagus. The test is indicated for use in patients with endoscopic biopsy-confirmed BO that is graded as non-dysplastic (NDBE), indefinite for dysplasia (IND), or low-grade dysplasia (LGD).
Castle’s chief operating officer, Kristen Oelschlager said: “We are proud of the expansion of our New York Clinical Laboratory Permit to include our TissueCypher test.
“We believe this shift from conditional to full approval by the NYSDOH exemplifies Castle’s commitment to providing high-quality, molecular tests that can guide informed care decisions and improve patients’ lives.”
Castle’s president and CEO, Derek Maetzold added: “Successful completion of the rigorous New York state assay review process for TissueCypher, which involves a meticulous review of a test’s analytical validity, clinical validity and clinical utility, is an important step toward ensuring all patients with BO in the United States have access to our test.”
The approval also means that all tests in Castle’s dermatology, gastroenterology, and ophthalmology portfolios, along with its clinical laboratories in Phoenix and Pittsburgh, are now approved by the State of New York.
In November 2024, data from the Castle Biosciences DECIDE study showed that using the DecisionDx-Melanoma test resulted in a 25% reduction in unnecessary sentinel lymph node biopsy in cancer patients.
